System and method for adapting alarms in a wearable medical device

ABSTRACT

A wearable defibrillator includes one or more environmental sensors including an accelerometer, one or more ECG sensors configured to acquire ECG data, and an alarm manager and at least one processor operatively coupled to the one or more ECG sensors and the accelerometer. The at least one processor is configured to detect a cardiac abnormality in the patient, identify a notification having one or more characteristics, and detect an environmental condition of the wearable defibrillator. The accelerometer is configured to detect a presence or lack of patient motion, and/or detect a body position of the patient as the detected environmental condition. The at least one processor is configured to determine whether one or more factors exist that inhibit the patient&#39;s ability to recognize the notification, on determining their existence, adapt the one or more characteristics of the notification and provide an adapted notification, and issue the adapted notification.

RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 120 as a continuationof U.S. patent application Ser. No. 16/929,367, entitled “SYSTEM ANDMETHOD FOR ADAPTING ALARMS IN A WEARABLE MEDICAL DEVICE,” filed Jul. 15,2020, which claims priority under 35 U.S.C. § 120 as a continuation ofU.S. patent application Ser. No. 16/298,390, entitled “SYSTEM AND METHODFOR ADAPTING ALARMS IN A WEARABLE MEDICAL DEVICE,” filed Mar. 11, 2019,now U.S. Pat. No. 10,755,547, which claims priority under 35 U.S.C. §120 as a continuation of U.S. patent application Ser. No. 15/965,287,entitled “SYSTEM AND METHOD FOR ADAPTING ALARMS IN A WEARABLE MEDICALDEVICE,” filed Apr. 27, 2018, now U.S. Pat. No. 10,269,227, which claimspriority under 35 U.S.C. § 120 as a continuation of U.S. patentapplication Ser. No. 15/483,203, entitled “SYSTEM AND METHOD FORADAPTING ALARMS IN A WEARABLE MEDICAL DEVICE,” filed Apr. 10, 2017, nowU.S. Pat. No. 9,990,829, which claims priority under 35 U.S.C. § 120 asa continuation of U.S. patent application Ser. No. 15/159,557, entitled“SYSTEM AND METHOD FOR ADAPTING ALARMS IN A WEARABLE MEDICAL DEVICE,”filed May 19, 2016, now U.S. Pat. No. 9,659,475, which claims priorityunder 35 U.S.C. § 120 as a continuation of U.S. patent application Ser.No. 14/704,033, entitled “SYSTEM AND METHOD FOR ADAPTING ALARMS IN AWEARABLE MEDICAL DEVICE,” filed May 5, 2015, now U.S. Pat. No.9,378,637, which claims priority under 35 U.S.C. § 120 as a continuationof U.S. patent application Ser. No. 13/428,703, entitled “SYSTEM ANDMETHOD FOR ADAPTING ALARMS IN A WEARABLE MEDICAL DEVICE,” filed Mar. 23,2012, now U.S. Pat. No. 9,135,398, which claims priority under 35 U.S.C.§ 119(e) to U.S. Provisional Patent Application Ser. No. 61/467,663,entitled “SYSTEM AND METHOD FOR ADAPTING ALARMS IN A WEARABLE MEDICALDEVICE,” filed on Mar. 25, 2011. U.S. patent application Ser. No.13/428,703 also claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application Ser. No. 61/542,749, entitled “SYSTEM ANDMETHOD FOR ADAPTING ALARMS IN A WEARABLE MEDICAL DEVICE,” filed on Oct.3, 2011. The disclosures of each of these related applications arehereby incorporated herein by reference in their entireties.

BACKGROUND Technical Field

Aspects of the present invention relate to medical devices, and moreparticularly to apparatus and methods for adapting alarms in medicaldevices.

Discussion of Related Art

Some wearable medical devices notify patients wearing the medical deviceof events of interest to the patient. In certain situations, wearablemedical devices receive responses to these notifications from thepatient. For instance, a wearable defibrillator worn by an ambulatorypatient generates an alarm if the patient's electrocardiogram (ECG)signal indicates a cardiac abnormality. Where the ECG signal indicatesthat the cardiac abnormality is treatable via a therapeutic shock, thewearable defibrillator must receive a response to this notification ifthe patient wishes to avoid the administration of an unnecessarytherapeutic shock.

In situations where the cause of a notification is not as pressing, awearable medical device may repeatedly notify a patient of the event ofinterest. For example, if a battery installed in the wearable medicaldevice is running low on power, the wearable medical device may notifythe patient. After a period of time, if the wearable medical devicecontinues to detect that the battery has a low power state, the wearablemedical device may reissue the previous notification. However, in thecase of a critical care medical device, such as the LifeVest® WearableCardioverter Defibrillator available from Zoll Medical Corporation ofChelmsford, Mass., lack of a responsive action by the patient may resultin the wearable defibrillator becoming inoperative due to lack ofbattery power.

SUMMARY

Examples disclosed herein adapt the characteristics of an alarm issuedby a wearable medical device to increase the efficacy of a wearablemedical device while maintaining or enhancing the usage experience ofpatients wearing the medical device. For instance, some adaptationspresented herein increase the probability that patients will respond tothe alarm in a suitable manner. Other adaptations tailor alarms to fitthe traits and preferences of particular patients. Thus, variousexamples address situations in which a patient does not hear an alarm,does not recognize the significance of an alarm or does not respondaccording to established timetables.

In one example, a method for adapting alarms issued by a wearablemedical device is provided. The method includes acts of issuing a firstinstance of an alarm; determining that no predetermined response to thefirst instance of the alarm was received within a target response time;adapting, responsive to determining that no predetermined response wasreceived within the target response time, at least one characteristic ofthe alarm according to an adaptation path associated with the alarm andissuing a second instance of the alarm, the second instance of the alarmhaving the at least one adapted characteristic.

In the method, the act of determining that the first instance of thealarm was not effective may include receiving no response within atarget response time. In addition, the act of adapting the at least onecharacteristic of the alarm may include increasing the intensity of thealarm. Further, the act of adapting the at least one characteristic ofthe alarm may include changing the conduit of the alarm. The act ofchanging the conduit of the alarm may include transmitting the alarm toa personal electronic device. Moreover, the method may further operateusing an alarm profile that indicates an alarm that is triggered uponoccurrence of an event. Additionally, the method may further includeacts of storing within the alarm profile, responsive to adapting the atleast one characteristic of the alarm, an association between the alarmand the adaptation path; detecting an occurrence of the event;identifying, responsive to detecting the occurrence of the event, theassociation between the alarm and the adaptation path; adapting,responsive to identifying the association, at least one characteristicof the alarm according to the adaptation path and issuing a thirdinstance of the alarm, the third instance of the alarm having the atleast one adapted characteristic.

According to another example, a method for adapting alarms issued by awearable medical device is provided. The method includes acts ofreceiving an alarm profile via an interface, the alarm profileindicating an alarm to be triggered upon occurrence of an event andincluding an association between an adaptation path and the alarm;detecting an occurrence of the event; identifying, responsive todetecting the occurrence of the event, the association between theadaptation path and the alarm; adapting, responsive to identifying theassociation, at least one characteristic of the alarm according to theadaptation path; and issuing an instance of the alarm having the atleast one adapted characteristic.

According to another example, a wearable medical device controller isprovided. The wearable medical device controller includes a memorystoring alarm profile information and a processor coupled to the memory.The processor being configured to issue a first instance of an alarm,determine that no predetermined response to the first instance of thealarm was received within a target response time, adapt, responsive todetermining that no predetermined response was received within thetarget response time, at least one characteristic of the alarm accordingto an adaptation path associated with the alarm and issue a secondinstance of the alarm, the second instance of the alarm having the atleast one adapted characteristic. In addition, the processor may beconfigured to determine that the first instance of the alarm was noteffective where the processor receives no response within a targetresponse time.

According to another example, a method for adapting alarms issued by awearable medical device is provided. The method includes acts ofdetecting an inhibiting factor associated with an alarm and adapting,responsive to detecting the inhibiting factor, at least onecharacteristic of the alarm according to an adaptation path.

According to another example, a method for adapting alarms issued by awearable medical device is provided. The method includes acts ofdetecting a correlation between a value of an independent variable andan alarm response pattern associated with a patient, determining, afterdetecting the correlation, that the independent variable has the valueand adapting, responsive to determining that the independent variablehas the value, an alarm based on the alarm response pattern.

According to another example, a wearable medical device controller isprovided. The device controller includes a memory and a processorcoupled to the memory. The processor is configured to determine acorrelation between a phenomenon identifiable by the wearable medicaldevice controller and at least one response pattern associated with apatient and store, responsive to detecting the correlation, anadaptation path to address the at least one response pattern, theadaptation path specifying an adaptation of at least one characteristicof an alarm. The at least one response pattern may include a pluralityof response patterns and the adaptation path may reflect adaptationsmade to address at least some of the plurality of response patterns.

In the device controller, the processor may be further configured todetect the phenomenon and adapt, responsive to detecting the phenomenon,the at least one characteristic of the alarm according to the adaptationpath. The processor may be configured to determine the correlation bydetermining a correlation between a value of an independent variableindicative of the phenomenon and the at least one response pattern.Adapting the at least one characteristic of the alarm may includeincreasing the intensity of the alarm. Adapting the at least onecharacteristic of the alarm may include changing the conduit of thealarm. Changing the conduit of the alarm may include transmitting thealarm to a personal electronic device. In some examples, the phenomenonmay be an inhibiting factor.

In the device controller, the memory may store an alarm profileindicating that the alarm be triggered upon occurrence of an event. Thealarm profile may include an association between the adaptation path andthe alarm. The processor may be further configured to detect anoccurrence of the event and issue a first instance of the alarm, thefirst instance having the at least one adapted characteristic. Theadaptation path may specify a plurality of adaptations and the processoris further configured to determine that no predetermined response to thefirst instance of the alarm was received within a target response time;adapt, responsive to determining that no predetermined response wasreceived within the target response time, a characteristic of the alarmaccording to an adaptation from the plurality of adaptations and issue asecond instance of the alarm, the second instance of the alarm havingthe adapted characteristic.

The device controller may further comprise an interface in datacommunication with the processor. The processor may be furtherconfigured to receive the alarm profile via the interface and store thealarm profile in the memory. The processor may be further configured toreceive a new adaptation path via the interface and store the newadaptation path in the alarm profile.

According to another example, a wearable medical device controller isprovided. The device controller includes a memory and a processorcoupled to the memory. The memory stores an alarm profile indicatingthat an alarm be triggered upon occurrence of an event and includes anassociation between an adaptation path and the alarm. The processor isconfigured to detect an occurrence of the event; issue a first instanceof the alarm; determine that no predetermined response to the firstinstance of the alarm was received within a target response time; adapt,responsive to determining that no predetermined response was receivedwithin the target response time, at least one characteristic of thealarm according to the adaptation path; and issue a second instance ofthe alarm, the second instance of the alarm having the at least oneadapted characteristic.

According to another example, method for adapting alarms issued by awearable medical device is provided. The method includes acts ofdetermining, by the wearable medical device, a correlation between aphenomenon identifiable by the wearable medical device and at least oneresponse pattern associated with a patient and storing, responsive todetecting the correlation, an adaptation path to address the at leastone response pattern, the adaptation path specifying an adaptation of atleast one characteristic of an alarm. The act of determining thecorrelation includes determining the correlation between the phenomenonand a plurality of response patterns and storing the adaptation pathincludes storing an adaptation path that reflects adjustments made toaddress at least some of the plurality of response patterns.

The method may further comprise acts of detecting the phenomenon andadapting, responsive to detecting the phenomenon, the at least onecharacteristic of the alarm according to the adaptation path. In themethod, the act of determining the correlation may include an act ofdetermining a correlation between a value of an independent variableindicative of the phenomenon and the at least one response pattern. Theact of adapting the at least one characteristic of the alarm may includeac act of increasing the intensity of the alarm. The act of adapting theat least one characteristic of the alarm may include changing theconduit of the alarm. The act of changing the conduit of the alarm mayinclude an act of transmitting the alarm to a personal electronicdevice.

The method may further comprise act of detecting an occurrence of anevent and issuing a first instance of the alarm, the first instancehaving the adaptation of the at least one characteristic of the alarm.The adaptation path may specify a plurality of adaptations and themethod further comprises acts of determining that no predeterminedresponse to the first instance of the alarm was received within a targetresponse time; adapting, responsive to determining that no predeterminedresponse was received within the target response time, a characteristicof the alarm according to an adaptation from the plurality ofadaptations and issuing a second instance of the alarm, the secondinstance of the alarm having the adapted characteristic.

Still other aspects, examples, and advantages of these exemplary aspectsand examples, are discussed in detail below. Moreover, it is to beunderstood that both the foregoing information and the followingdetailed description are merely illustrative examples of variousaspects, and are intended to provide an overview or framework forunderstanding the nature and character of the claimed subject matter.References to “an example,” “some examples,” “an alternate example,”“various examples,” “one example,” “at least one example,” “this andother examples” or the like are not necessarily mutually exclusive andare intended to indicate that a particular feature, structure, orcharacteristic described in connection with the example may be includedin that example and other examples. The appearances of such terms hereinare not necessarily all referring to the same example.

Furthermore, in the event of inconsistent usages of terms between thisdocument and documents incorporated herein by reference, the term usagein the incorporated references is supplementary to that of thisdocument; for irreconcilable inconsistencies, the term usage in thisdocument controls. In addition, the accompanying drawings are includedto provide illustration and a further understanding of the variousaspects and examples, and are incorporated in and constitute a part ofthis specification. The drawings, together with the remainder of thespecification, serve to explain principles and operations of thedescribed and claimed aspects and examples.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings are not intended to be drawn to scale. In thedrawings, components that are identical or nearly identical may berepresented by a like numeral. For purposes of clarity, not everycomponent is labeled in every drawing. In the drawings:

FIG. 1 is a functional schematic of one example of a wearable medicaldevice controller;

FIG. 2 is a flow diagram of one example of a process for adapting alarmsissued by a medical device;

FIG. 3 is a flow diagram of one example of a process for configuringinformation within an alarm profile;

FIG. 4 is a flow diagram of one example of a process for monitoringevents associated with a medical device; and

FIG. 5 is a flow diagram of one example of a process for producingalarms associated with a medical device.

DETAILED DESCRIPTION

Aspects and examples disclosed herein relate to apparatus and processesfor adapting alarms issued by a wearable medical device. The examplesdisclosed herein are potentially applicable to a wide variety ofwearable medical devices. In some examples, the wearable medical devicesare configured in accord with the wearable medical devices described inapplication Ser. No. 13/109,382, entitled WEARABLE AMBULATORY MEDICALDEVICE WITH MULTIPLE SENSING ELECTRODES, filed May 17, 2011, now U.S.Pat. No. 8,706,215, which is incorporated by reference herein in itsentirety. In other examples, the wearable medical device is a monitoringdevice that does not conduct a therapy delivery method or include atherapy delivery apparatus. In each of these examples, a control unit ofthe wearable medical device includes a set of components configured toperform the adaptation processes described herein. This set ofcomponents may include hardware components or a combination of hardwareand software components.

The examples of the methods and apparatuses discussed herein are notlimited in application to the details of construction and thearrangement of components set forth in the following description orillustrated in the accompanying drawings. The methods and apparatusesare capable of implementation in other examples and of being practicedor of being carried out in various ways. Examples of specificimplementations are provided herein for illustrative purposes only andare not intended to be limiting. In particular, acts, elements andfeatures discussed in connection with any one or more examples are notintended to be excluded from a similar role in any other examples.

Also, the phraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. Any references toexamples or elements or acts of the systems and methods herein referredto in the singular may also embrace examples including a plurality ofthese elements, and any references in plural to any example or elementor act herein may also embrace examples including only a single element.References in the singular or plural form are not intended to limit thepresently disclosed systems or methods, their components, acts, orelements. The use herein of “including,” “comprising,” “having,”“containing,” “involving,” and variations thereof is meant to encompassthe items listed thereafter and equivalents thereof as well asadditional items. References to “or” may be construed as inclusive sothat any terms described using “or” may indicate any of a single, morethan one, and all of the described terms.

Wearable Medical Device Controller

FIG. 1 illustrates a wearable medical device controller 100 that isconfigured to monitor a patient and the patient's environment for eventsof interest and to adapt notifications reporting these events. As shownin FIG. 1 , the wearable medical device controller 100 includes aprocessor 118, a sensor interface 112, an alarm manager 114, a therapydelivery interface 102, data storage 104, a communication networkinterface 106, a user interface 108 and a battery 110. The data storage104 includes alarm profile information 116. Further, in this illustratedexample, the battery 110 is a rechargeable 3 cell 2200 mAh lithium ionbattery pack that provides electrical power to the other devicecomponents with a minimum 24 hour runtime between charges.

According to the example illustrated in FIG. 1 , the processor 118 iscoupled to the sensor interface 112, the therapy delivery interface 102,the data storage 104, the network interface 106 and the user interface108. The processor 118 performs a series of instructions that result inmanipulated data which is stored in and retrieved from the data storage104. According to a variety of examples, the processor 118 is acommercially available processor such as a processor manufactured byTexas Instruments, Intel, AMD, Sun, IBM, Motorola, Freescale and ARMHoldings. However, the processor 118 may be any type of processor,multiprocessor or controller, whether commercially available orspecially manufactured. For instance, according to one example, theprocessor 118 may include a power conserving processor arrangement suchas described in application Ser. No. 12/833,096, entitled SYSTEM ANDMETHOD FOR CONSERVING POWER IN A MEDICAL DEVICE, filed Jul. 9, 2010, nowU.S. Pat. No. 8,904,214 (hereinafter the “'096 application”), which isincorporated by reference herein in its entirety. In another example,the processor 118 is an Intel® PXA270.

In addition, in several examples the processor 118 is configured toexecute a conventional RTOS, such as RTLinux. In these examples, theRTOS may provide platform services to application software, such as someexamples of the alarm manager 114 which is discussed further below.These platform services may include inter-process and networkcommunication, file system management and standard databasemanipulation. However, one of many operating systems may be used, andexamples are not limited to any particular operating system or operatingsystem characteristic. For instance, in some examples, the generalpurpose processor 118 may be configured to execute a non-real timeoperating system, such as BSD or GNU/Linux.

The alarm manager 114 is configured to manage alarm profiles, such asthe alarm profile information 116, and notify one or more intendedrecipients of events specified within the alarm profiles as being ofinterest to the intended recipients. These intended recipients mayinclude external entities such as users (patients, physicians, andmonitoring personnel) as well as computer systems (monitoring systems oremergency response systems). The alarm manager 114 is also configured toadapt notifications according to an adaptation path specified within thealarm profile information 116. Adaptation paths are discussed furtherbelow with reference to the alarm profile information 116.

The alarm manager 114 may be implemented using hardware or a combinationof hardware and software. For instance, in one example, the alarmmanager 114 is implemented as a software component that is stored withinthe data storage 104 and executed by the processor 118. In this example,the instructions included in the alarm manager 114 program the processor118 to configure alarm profiles and notify intended recipients using thealarm profiles. In other examples, alarm manager 114 may be anapplication-specific integrated circuit (ASIC) that is coupled to theprocessor 118 and tailored to manage alarm profiles and notify intendedrecipients using alarms specified within the alarm profiles. Thus,examples of alarm manager 114 are not limited to a particular hardwareor software implementation. Particular examples of the processesperformed by the alarm manager 114 are discussed further below withreference to FIGS. 2-5 and the Example Alarm Adaptations section below.

In some examples, the components disclosed herein, such as the alarmmanager 114, may read parameters that affect the functions performed bythe components. These parameters may be physically stored in any form ofsuitable memory including volatile memory, such as RAM, or nonvolatilememory, such as a magnetic hard drive. In addition, the parameters maybe logically stored in a propriety data structure, such as a database orfile defined by a user mode application, or in a commonly shared datastructure, such as an application registry that is defined by anoperating system. In addition, some examples provide for both system anduser interfaces, as may be implemented using the user interface 108,that allow external entities to modify the parameters and therebyconfigure the behavior of the components.

For example, the alarm manager 114 includes an alarm mode parameter. Thealarm mode parameter indicates a generalized set of preferences that thealarm manager 114 applies to triggered alarms. The alarm manager 114 mayadjust any characteristics of an alarm depending on the particular alarmmode currently in effect. Example alarm modes include, but are notlimited to, normal (no modification to alarm characteristics), silent(do not produce sensory output to one or more senses when reporting thealarm), loud (increase sensory output to one or more senses whenreporting the alarm), vehicle (decrease sensory output and targetresponse times, delay alarms with adaptation paths indicating to delaythe alarm if the alarm mode parameter indicates vehicle mode, issuetriggered alarms through an in-vehicle communications and entertainmentsystem if available), walking (issue triggered alarms via an outputembedded within an article of clothing, such as a foot buzzer), andpersonal electronic device (issue triggered alarms via a personalelectronic device such as an earpiece, phone, tablet computing device,pen, personal entertainment device, sport equipment, personal digitalassistant, etc. . . . ).

The data storage 104 includes a computer readable and writeablenonvolatile data storage medium configured to store non-transitoryinstructions and other data. In addition, the data storage 104 includesa processor memory that stores data during operation of the processor118. In some examples, the processor memory includes a relatively highperformance, volatile, random access memory such as dynamic randomaccess memory (DRAM), static memory (SRAM) or synchronous DRAM. However,the processor memory may include any device for storing data, such as anon-volatile memory, with sufficient throughput and storage capacity tosupport the functions described herein. According to several examples,the processor 118 causes data to be read from the nonvolatile datastorage medium into the processor memory prior to processing the data.In these examples, the processor 118 copies the data from the processormemory to the non-volatile storage medium after processing is complete.A variety of components may manage data movement between thenon-volatile storage medium and the processor memory and examples arenot limited to particular data management components. Further, examplesare not limited to a particular memory, memory system or data storagesystem.

The instructions stored on the data storage 104 may include executableprograms or other code that can be executed by the processor 118. Thedata storage 104 also may include information that is recorded, on orin, the medium, and this information may be processed by the processor118 during execution of instructions. More specifically, the informationmay be stored in one or more data structures specifically configured toconserve storage space or increase data exchange performance. Theinstructions may be persistently stored as encoded signals, and theinstructions may cause the processor 118 to perform the functionsdescribed herein. The medium may, for example, be optical disk, magneticdisk or flash memory, among others, and may be permanently affixed to,or removable from, the wearable medical device controller 100.

The alarm profile information 116 includes data used by the alarmmanager 114 to notify intended recipients of events of interest. Moreparticularly, according to the illustrated example, the alarm profileinformation 116 includes information that identifies events of interest,characteristics of one or more alarms used to report the identifiedevents and one or more adaptation paths for each of the one or morealarms. Events of interest may include any event detectable by thewearable medical device controller 100. However, in broad terms, eventsof interest may be categorized as concerning the patient wearing thewearable medical device, such as an indication of a physiologicalabnormality in the patient, or concerning the wearable medical deviceitself, such as a component in need of service (for example, a lowbattery).

Common alarm characteristics include an alarm identifier, an intendedrecipient of the alarm, one or more potential responses, a conduitthrough which the alarm is provided, content for the alarm, an intensitywith which the content is communicated, an issuance rate at which thecontent is communicated and a target response time. The conduits throughwhich alarms may be issued include, among others, the user interface108, the network interface 106 and the therapy delivery interface 102.Adaptation paths may specify initial characteristics of alarms and howthe characteristics of the alarms are altered based on the currentlyselected alarm mode, the number of times the alarms have issued, thecircumstances surrounding the intended recipients of any alarms and anyresponsive actions taken, or not taken, by the external entities. Ingeneral, the adaptations specified by adaptation paths involve actionssuch as increasing the intensity with which an alarm is communicated,altering the content or conduit of an alarm and increasing the issuancerate with which an alarm is communicated. Specific examples ofadaptation paths that are specified with the alarm profile information116 and that the alarm manager 114 is configured to conduct arediscussed further below within the Example Alarm Adaptations section.

As illustrated in FIG. 1 , the alarm manager 114 and the alarm profileinformation 116 are separate components. However, in other examples, thealarm manager 114 and the alarm profile information 116 may be combinedinto a single component or re-organized so that a portion of the dataincluded in the alarm manager 114, such as executable code that causesthe processor 118 to adapt a triggered alarm, resides in the alarmprofile information 116, or vice versa. Such variations in these and theother components illustrated in FIG. 1 are intended to be within thescope of the examples disclosed herein.

The alarm profile information 116 may be stored in any logicalconstruction capable of storing information on a computer readablemedium including, among other structures, flat files, indexed files,hierarchical databases, relational databases or object orienteddatabases. In addition, various examples organize the alarm profileinformation 116 into particularized and, in some cases, uniquestructures to perform the functions disclosed herein. In these examples,the data structures are sized and arranged to store values forparticular types of data.

As shown in FIG. 1 , the wearable medical device controller 100 includesseveral system interface components 102, 106 and 112. Each of thesesystem interface components is configured to exchange, i.e. send orreceive, data with one or more specialized devices that may be locatedwithin the wearable medical device controller 100 or elsewhere. Thecomponents used by the interfaces 102, 106 and 112 may include hardwarecomponents, software components or a combination of both. In theinstance of each interface, these components physically and logicallycouple the wearable medical device controller 100 to the specializeddevices. This physical and logical coupling enables the wearable medicaldevice controller 100 to both communicate with and, in some instances,control the operation of the specialized devices. These specializeddevices may include physiological sensors, therapy delivery devices andcomputer networking devices.

According to various examples, the hardware and software components ofthe interfaces 102, 106 and 112 employ a variety of coupling andcommunication techniques. In some examples, the interfaces 102, 106 and112 use leads, cables or other wired connectors as conduits to exchangedata between the wearable medical device controller 100 and specializeddevices. In other examples, the interfaces 102, 106 and 112 communicatewith specialized devices using wireless technologies such as radiofrequency or infrared technology. The software components included inthe interfaces 102, 106 and 112 enable the processor 118 to communicatewith specialized devices. These software components may include elementssuch as objects, executable code and populated data structures.Together, these software components provide software interfaces throughwhich the processor 118 can exchange information with specializeddevices. Moreover, in at least some examples where one or morespecialized devices communicate using analog signals, the interfaces102, 106 and 112 further include components configured to convert analoginformation into digital information, and visa-versa, to enable theprocessor 118 to communicate with specialized devices.

As discussed above, the system interface components 102, 106 and 112shown in the example of FIG. 1 support different types of specializeddevices. For instance, the components of the sensor interface 112 couplethe processor 118 to one or more physiological sensors such as a bodytemperature sensors, respiration monitors, and dry capacitive ECGelectrodes, one or more environmental sensors such as atmosphericthermometers, airflow sensors, video sensors, audio sensors,accelerometers, GPS locators, and hygrometers. In these examples, thesensors may include sensors with a relatively low sampling rate, such aswireless sensors.

The components of the therapy delivery interface 102 couple one or moretherapy delivery devices, such as capacitors and defibrillatorelectrodes, to the processor 118. In addition, the components of thenetwork interface 106 couple the processor 118 to a computer network viaa networking device, such as a bridge, router or hub. According to avariety of examples, the network interface 106 supports a variety ofstandards and protocols, examples of which include USB (via, forexample, a dongle to a computer), TCP/IP, Ethernet, Wireless Ethernet,Bluetooth, ZigBee, M-Bus, CAN-bus, IP, IPV6, UDP, DTN, HTTP, FTP, SNMP,CDMA, NMEA and GSM. To ensure data transfer is secure, in some examples,the wearable medical device controller 100 can transmit data via thenetwork interface 106 using a variety of security measures including,for example, TLS, SSL or VPN. In other examples, the network interface106 includes both a physical interface configured for wirelesscommunication and a physical interface configured for wiredcommunication. According to various embodiments, the network interface106 enables communication between the wearable medical device controller100 and a variety of personal electronic devices including computerenabled glasses and earpieces.

Thus, the various system interfaces incorporated in the wearable medicaldevice controller 100 allow the device to interoperate with a widevariety of devices in various contexts. For instance, some examples ofthe wearable medical device controller 100 are configured to perform aprocess of sending critical events and data to a centralized server viathe network interface 106. An illustration of a process in accord withthese examples is disclosed in U.S. Pat. No. 6,681,003, entitled “DATACOLLECTION AND SYSTEM MANAGEMENT FOR PATIENT-WORN MEDICAL DEVICES” andissued on Jan. 20, 2004 which is hereby incorporated by reference in itsentirety.

As illustrated in FIG. 1 , the therapy delivery interface 102 and thenetwork interface 106 are optional and may not be included in everyexample. For instance, a heart rate monitor may employ the wearablemedical device controller 100 to issue adaptive alarms but may notinclude a therapy delivery interface 102 to treat cardiac abnormalities.Similarly, a wearable defibrillator may include the wearable medicaldevice controller 100 to provide adaptive alarm functionality but maynot include a network interface 106 where, for example, the wearabledefibrillator is designed to rely on the user interface 108 to announcealarms.

The user interface 108 shown in FIG. 1 includes a combination ofhardware and software components that allow the wearable medical devicecontroller 100 to communicate with an external entity, such as a user.These components are configured to receive information from actions suchas physical movement, verbal intonation or thought processes. Inaddition, the components of the user interface 108 can provideinformation to external entities. Examples of the components that may beemployed within the user interface 108 include keyboards, mouse devices,trackballs, microphones, electrodes, touch screens, printing devices,display screens and speakers. In some examples, the electrodes includean illuminating element, such as an LED. In other examples, the printingdevices include printers capable of rendering visual or tactile(Braille) output.

The wearable medical device controller 100 has a variety of potentialapplications and is well suited to devices that notify external entitiesof a variety of events, some of which require a predetermined responsefrom the external entity. Predetermined responses may include anyresponse that is appropriate given the event being reported.Predetermined responses may include acknowledgment of the alarm, entryof information indicating that the alarm is being addressed andrectification of the event or condition that triggered the alarm.Examples of devices to which the wearable medical device controller 100is well suited include critical care medical devices, such as a wearableexternal defibrillator. An example of one such defibrillator isdescribed in the '096 application with reference to FIG. 3 . In at leastone example, the wearable defibrillator 300 illustrated in FIG. 3 of the'096 application employs the wearable medical device controller 100, asdisclosed in the present application, as a substitute for the portabletreatment controller 200 described in the '096 application. In thisexample, the ECG Electrodes and Therapy Pads illustrated in FIG. 3 ofthe '096 application are logically and physically coupled to thewearable medical device controller 100 via the sensor interface 112 andthe therapy delivery interface 102, respectively.

Alarm Adaptation Processes

Various examples provide processes through which a medical device adaptsalarms that report events of interest to one or more intendedrecipients. In these examples, the medical device is arranged to includethe wearable medical device controller 100 and performs the actsdisclosed herein, including the acts described in the Example AlarmAdaptations section below. FIG. 2 illustrates one such process 200 thatincludes acts of configuring alarm profiles, monitoring events andproducing alarms. Process 200 begins at 202.

In act 204, the medical device configures alarm profile information.According to some examples, an alarm manager, such as the alarm manager114, implements a configuration interface through which the alarmmanager receives alarm profile information from a user, such as apatient, physician or equipment technician. Acts in accord with theseexamples are discussed below with reference to FIG. 3 .

In act 206, the medical device monitors events. According to a varietyof examples, the alarm manager monitors the various inputs of themedical device for events of interest as specified in alarm profileinformation, such as the alarm profile information 116. Acts in accordwith these examples are discussed below with reference to FIG. 4 .

In act 208, the medical device produces an alarm. According to a variousexamples, the alarm manager adapts and issues the alarm in accord withthe alarm profile information. Acts in accord with these examples arediscussed below with reference to FIG. 5 .

In act 210, the medical device determines if an interruption inmonitoring is about to commence, such as an interruption caused byshutdown of the wearable medical device controller. If so, the medicaldevice proceeds to 212. Otherwise the medical device returns to act 206.

Process 200 ends at 212. Examples in accord with process 200 allow amedical device to notify intended recipients, such as the patient, aphysician or monitoring personnel, of important events in a manner thatdecreases the likelihood that the alarm will be ignored. Thus, suchexamples increase the efficacy of the medical device.

As discussed above with regard to act 204 shown in FIG. 2 , variousexamples provide processes for configuring alarm profiles by a medicaldevice. FIG. 3 illustrates one such process 310 that implements act 204and that includes acts of providing a configuration interface, receivingalarm profile information and storing the alarm profile information. Amedical device implementing process 310 begins at 312.

In act 314, an alarm manager, such as the alarm manager 114, provides aconfiguration interface through which the alarm manager receives alarmprofile information, such as the alarm profile information 116. Thecharacteristics of the configuration interface vary from example toexample. For instance, in one example, the configuration interfacepresents, via the user interface 108, one or more screens arranged toreceive information identifying an alarm, an intended recipient of thealarm, one or more potential responses, a conduit through which thealarm is provided, content for the alarm, an intensity with which thecontent is communicated, an issuance rate with which the content iscommunicated, a target response time and an adaptation path for thealarm. According to another example, the configuration interfaceincludes a system interface implemented via a network interface, such asthe network interface 106, and through which the alarm manager receivesalarm profile information from an external system. In one example, theexternal system is a web site through which external entities, such aspatients or monitoring personnel, may configure alarm profileinformation for download to the wearable medical device controller.Other examples detailing characteristics of the configuration interfaceprovided are discussed below in the Example Alarm Adaptations section.

In act 316, the alarm manager receives alarm profile information via theconfiguration interface. For instance, in one example, the configurationinterface receives an intended recipient of the alarm, one or morepotential responses, a conduit through which the alarm is provided,content for the alarm, an intensity with which the content iscommunicated, an issuance rate with which the content is communicated, atarget response time and an adaptation path for the alarm via thescreens described above. In another example, the alarm profileinformation is received from the external system described above. In act318, the alarm manager stores the alarm profile information in datastorage, such as the data storage 104. A medical device implementingprocess 310 terminates the process at 320. Examples in accord withprocess 310 enable medical devices to gather alarm profile informationfor later use in reporting and adapting alarms.

As discussed above with regard to act 206 shown in FIG. 2 , variousexamples provide processes for monitoring events encountered in amedical device. FIG. 4 illustrates one such process 400 that may be usedto implement act 206 and that includes acts of receiving eventinformation, determining if the event triggers an alarm, and triggeringan alarm. A medical device implementing process 400 begins at 402.

In act 404, an alarm manager, such as the alarm manager 114, receives anevent from the processor 118. In act 406, the alarm manager determinesif the event triggers an alarm by referencing alarm profile information,such as the alarm profile information 116. If so, the alarm managertriggers the alarm in act 408. Otherwise the alarm manager proceeds to410. A medical device implementing process 400 terminates the process at410. Examples in accord with process 400 enable medical devicesdetermine if an event encountered by the device triggers an alarm.

As discussed above with regard to act 208 shown in FIG. 2 , variousexamples provide processes for producing alarms by medical devices. FIG.5 illustrates one such process 500 that may be used to implement act 208and that includes acts of retrieving alarm profiles, determining alarmcharacteristics and issuing an alarm. A medical device implementingprocess 500 begins at 502.

In act 504, an alarm manager, such as the alarm manager 114, retrievesalarm profile information, such as the alarm profile information 116,from a data storage, such as the data storage 104. In act 506, the alarmmanager determines the alarm characteristics based on the alarm profileinformation and the alarm mode parameter. In one example, the alarmmanager determines if the alarm has previously been issued but nopredetermined response has been received. In this is the situation, thealarm manager adapts the alarm according to the adaptation pathassociated with the alarm. Further, in some examples, the alarm managermay record this adaptation so that future instances of the alarm areadapted automatically, i.e. without requiring the issuance of anineffective alarm. In another example, the alarm manager determines,prior to issuing any alarm instances, that an alarm profile indicatesinstances of the alarm should be adapted according to the adaptationpath and the alarm manager adapts the alarm accordingly. In anotherexample, the alarm manager determines if the environment of the intendedrecipient of the alarm is such that the alarm should be adapted and, ifso, adapts the alarm according to the adaptation path associated withthe alarm. Other examples detailing characteristics and adaptations ofalarms are discussed below in the Example Alarm Adaptations section.

In act 508, the alarm manager issues the alarm with the characteristicsas determined in act 506. A medical device implementing process 500terminates the process at 510. Examples in accord with process 500enable medical devices to issue alarms that are adapted to effectivelynotify the intended recipient of the alarm. This, in turn, increases thelikelihood that the intended recipient will perform any actions requiredto suitably respond to the alarm, thereby benefiting the wearer of themedical device.

Each of the processes disclosed herein depicts one particular sequenceof acts in a particular example. The acts included in each of theseprocesses may be performed by, or using, a medical device speciallyconfigured as discussed herein. Some acts are optional and, as such, maybe omitted in accord with one or more examples. Additionally, the orderof acts can be altered, or other acts can be added, without departingfrom the scope of the systems and methods discussed herein. In addition,as discussed above, in at least one example, the acts are performed on aparticular, specially configured machine, namely a medical deviceconfigured according to the examples disclosed herein.

Example Alarm Adaptations

According to various examples, an alarm manager, such as the alarmmanager 114, performs a wide variety of actions with reference toadaptation paths specified in alarm profile information, such as thealarm profile information 116. For instance, in some examples, the alarmmanager receives, via a configuration interface as discussed above, anadaptation path specifying that the alarm manager should initially issuean alarm via one or more conduits and later, if necessary, adapt thealarm to different or multiple conduits. These conduits may communicate,or cause other devices to communicate, with the intended recipient viadifferent sensory outputs such as optical (a display, LED, illuminatedelectrode, etc. . . . ), auditory (a speaker), and tactile (vibratingoutput) outputs. In at least one example, the adaptation path specifiesthat the alarm be initially issued as a vibration alarm and subsequentlybe adapted to a voice instruction using a voice selected by a user viathe configuration interface. According to these examples, the alarmmanager issues the alarm according to the adaptation path when the alarmis triggered by an event.

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path specifying a duration threshold for theamount of time an alarm may be silenced by an external entity. In theseexamples, the adaptation path further specifies that the alarm managershould, if the alarm is silenced beyond the threshold and no responsiveaction has been taken, adapt the alarm by increasing the intensity orissuance rate of the alarm or by changing the conduit through which thealarm is communicated. According to these examples, the alarm managerissues the alarm according to the adaptation path when the alarm istriggered by an event. Further, according to one example, the alarmmanager adapts, in accord with information specified in the adaptationpath, the alarms silenced beyond the threshold by changing the alarmfrom a tone to a voice command requesting that the intended recipienttake a particular action.

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path specifying that if no response is receivedfrom an external entity within a specified response time, the alarmmanager should increase the intensity of an alarm, for example increasethe volume in the case of an auditory alarm. According to theseexamples, the alarm manager issues the alarm according to the adaptationpath when the alarm is triggered by an event.

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path specifying that if no response is receivedfrom an external entity within a specified response time, the alarmmanager should change the content of an alarm, for example change from atone to a voice command in the case of an auditory alarm. According tothese examples, the alarm manager issues the alarm according to theadaptation path when the alarm is triggered by an event.

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path specifying that if no response is receivedfrom an external entity within a specified response time, the alarmmanager should modify the issuance rate with which an alarm is beingreported, for example decrease the duration between re-issuances of thealarm. According to these examples, the alarm manager issues the alarmaccording to the adaptation path when the alarm is triggered by anevent.

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path specifying that if no response is receivedfrom an external entity within a specified response time, the alarmmanager should modify the sensory output through which an alarm is beingreported, for example change from auditory to visual indicia orvisa-versa. According to these examples, the alarm manager issues thealarm according to the adaptation path when the alarm is triggered by anevent.

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path specifying that if no response is receivedfrom an external entity within a specified response time, the alarmmanager should modify the content of an alarm, for example change from agentle gong to an ear-piercing siren in the case of an auditory alarm.According to these examples, the alarm manager issues the alarmaccording to the adaptation path when the alarm is triggered by anevent.

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path specifying that if no response is receivedfrom an external entity within a specified response time, the alarmmanager should modify the conduit through which an alarm is reported,for example change the reporting device from the wearable medical devicecontroller to another device associated with the intended recipient.These other devices may include personal electronic devices (such assmart phones, PDAs, wired and wireless headphones or headsets, andtablet computing devices), computer systems (through which alarms may bereported via, for example, on-screen pop-ups), home base stations,bedside radios, televisions (through which alarms may be reported, forexample, via on-screen pop-ups or widgets), cars or any otheraddressable device with an output. According to these examples, thealarm manager issues the alarm according to the adaptation path when thealarm is triggered by an event.

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path specifying that the alarm manager issue analarm to a device other than the wearable medical device prior toissuing the alarm to the wearable medical device. For instance, in oneexample, the adaptation path specifies that the alarm manager issue analarm via a call to an intended recipient's phone. In another example,the adaptation path specifies that the alarm manager issue an alarmthrough a Bluetooth headset paired with the wearable medical device. Instill another example, the adaptation path specifies that the alarmmanager issue an alarm via a text message sent to the intendedrecipient's phone. In all of these examples, if a response is notreceived by the wearable medical device within a target response time,the alarm manager issues the alarm via the wearable medical device.

As with other adaptation paths, this adaptation path may be configuredto apply to one or more specific events of interest. For example, wherethe event of interest is detection of a misplaced or improperly attachedelectrode, the adaptation path may specify that the alarm manager firstissue an alarm specifying the color of the misplaced or improperlyattached electrode. Alternatively, this adaptation path may specify thatthe alarm manager first issue an alarm by illuminating an LED includedwithin the misplaced or improperly attached electrode. In anotherexample, the adaptation path may specify that the alarm manager alsoissue an alarm via the user interface that specifies the color of theelectrode. In another example where the event of interest is passage ofa threshold amount of time since a battery included within the wearablemedical device has been replaced, the adaptation path may specify thatthe alarm manager first issue an alarm by sending a text to the phone ofan intended recipient.

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path specifying that if no response is receivedfrom an external entity within a specified response time, the alarmmanager should modify the intended recipient to a list of intendedrecipients including, for example, family members of a patient or localemergency response personnel. According to these examples, the alarmmanager issues the alarm according to the adaptation path when the alarmis triggered by an event.

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path specifying that if no response is receivedfrom an external entity within a specified response time, the alarmmanager should, prior to each issuance of an alarm, iterate one or morecharacteristics of the alarm through a set of values, thereby alteringthe characteristics of the alarm each time it is issued. This iterationmay cycle through the values and may modify any of the characteristicsof the alarm including the intensity, issuance rate, content and conduitof the alarm. According to these examples, the alarm manager issues thealarm according to the adaptation path when the alarm is triggered by anevent.

In other examples, the alarm manager adjusts the target response timefor one or more alarms based on the average patient response time to thealarms. For instance, if the alarm manager detects that the averageresponse time plus a predefined acceptable margin is less than thetarget response time, the alarm manager may modify the target responsetime to be equal to the average response time plus the predefinedmargin.

In other examples, the alarm manager determines, prior to issuance of analarm, if factors exist that may inhibit the intended recipient's (orbystander's) ability to recognize the alarm. Exemplary inhibitingfactors include environmental characteristics, such as excessive sensorystimulation, patient characteristics, such as the physical, mental oremotional state of the patient, and characteristics affecting thewearable medical device. Where an inhibiting factor is present, thealarm manager adapts the alarm to increase the likelihood that the alarmwill be recognized despite the presence of the inhibiting factor. Suchadaptations may include extending the target response time by somepredetermined amount, adjusting the intensity of the alarm or both. Inthe case of an audio alarm, adjusting the intensity may includeadjusting the amplitude or the frequency of the alarm. In otherexamples, the alarm manager detects the amount of motion or the ambientnoise level of the environment of the intended recipient to determine ifthese factors may be inhibiting recognition of the alarm. According tothese examples, the alarm manager extends the target response time oradjusts the intensity of the alarm upon determining that the motion orthe ambient noise level is above a predetermined threshold.

In other examples, the alarm manager determines, via a hygrometer suchas the hygrometer described above, the relative humidity of the currentenvironment of the wearable medical device and alters the audio alarmcharacteristics to be more tolerant of the environmental conditions. Forinstance, in these examples, the alarm manager may increase the targetresponse time or increase the volume of an audio alarm to compensate forthe relatively high sound absorption present in a high humidityenvironment.

In other examples, the alarm manager determines whether the wearablemedical device is properly fitted to the patient. In these examples, ifthe alarm manager determines that the wearable medical device is notproperly fitted, the alarm manager adapts alarms to overcome thisinhibiting factor. For instance, the alarm manager may increase theintensity of a tactile alarm to increase the likelihood that a patientwearing a loose-fitting medical device feels the tactile alarm.Alternatively, the alarm manger may change the tactile alarm to anauditory alarm.

In another example, the alarm manager uses audio input or physiologicaldata to determine if the mood or stress level of the patient may be aninhibiting factor or may affect the patient's response to an alarm. Inthis example, where the intended recipient appears to be undergoingstress, the alarm manager decreases the intensity or the duration of thealarm to prevent panic or some other negative or volatile reaction tothe alarm. In another instance, where the patient appears to be lying inresponse to an alarm, the alarm manager repeats the alarm or alters thealarm to verify the veracity of the response. Other adaptations may beperformed in response to alarm inhibiting factors and examples are notlimited to particular adaptation paths or inhibiting factors.

Some wearable medical devices are continuously or nearly continuouslyworn by patients for extended periods of time. In fact, in certainsituations, these periods of time can extend to two months or more. Overthese extended time periods, some patients repeatedly displayparticularized alarm response patterns. For instance, a patient whocommutes to work in the morning, takes lunch at midday, commutes home inthe evening and sleeps at night may display a repeatedly delayedresponse pattern at particular points during the day, such as during themorning and evening commutes, or when the patient is asleep.

According to various examples, the alarm manager analyzes alarm responsedata for repeating patterns and adapts alarms issued according to anadaptation path that addresses the repeating pattern. More particularly,in some of these examples, the alarm manager identifies the number offalse alarms (e.g. alarms responded to by canceling treatment) thatoccur over a period of time. In these examples, the alarm managercompares the number of false alarms to a threshold value. If the numberof false alarms exceeds the threshold value, the alarm manager reportsthis event to the patient and provides the patient with a set ofcorrective actions specific to the type of false alarm encountered.

In other examples, the alarm manager determines correlations betweenvalues of independent variables that represent a phenomenon and atendency for a patient to respond to alarms in a particular way (i.e.,follow a particular alarm response pattern). This phenomenon may be anyphenomenon quantifiable and identifiable by the wearable medical devicevia sensors or other facilities disclosed herein. Examples ofidentifiable phenomenon include one or more events as described herein,a predetermined series of events occurring over a predefined span oftime, a physical circumstance, such as the time of day, andphysiological measurements. According to some examples, the alarmmanager may determine correlations by analyzing information describingalarms and responses to alarms as this information is processed by thewearable medical device. The alarm manager may periodically scan ahistory of this alarm response data that is compiled by the alarmmanager during its normal operation. In one example, the alarm managerscans the history of alarm response patterns daily, while in anotherexample, the alarm manager performs this analysis on a weekly or monthlybasis. It is to be appreciated that, in some of these examples, thealarm manager determines correlations from population samples that varyin size and whose values are recorded over an extended period of time.Thus, in these examples, the correlations reflect multiple, discretealarms and response episodes.

In some examples, the alarm manager identifies one or more correlationsof interest between independent variables and patient response patterns.In one example, the alarm manager identifies interesting correlations bydetermining that a value of a correlation exceeds a predeterminedthreshold. In other examples, the alarm manager automatically createsone or more alarm profiles for each interesting correlation. In theseexamples, the alarm manager stores one or more adaptation paths withinthe automatically created alarm profiles. These adaptation paths specifyadaptations that address the correlated patient response pattern (i.e.,adaptations to alarm characteristics that improve the efficacy of thealarm). Some specific examples of the adaptations performed by the alarmmanager when implementing these adaptation paths are described furtherbelow. It is to be appreciated that, in some examples, the alarm manageriteratively adjusts the adaptation path correlated with the patientresponse pattern over an extended period of time. In these examples, theadaptation path gradually improves as the alarm manager analyzes anincreasing number of discrete alarms and response episodes.

The alarm manager may adapt alarms to accommodate a repeating pattern ina variety of ways. For instance, to accommodate a period of time inwhich the patient is normally slow to respond, the alarm manager maysimply extend the target response time for any alarms issued.Alternatively, if the alarm is of sufficient importance, the alarmmanager may increase the intensity of the alarm or change the conduitused to communicate the alarm. In another example, to accommodate aphysiological indication that is correlated with delayed response timesby a patient (such as an indication exhibited by the patient duringsleep), the alarm manager may delay issuance of the alarm until thephysiological indication changes. Examples of the alarm manager maydetermine correlations between independent variables, other than time ofday or physiological data, and alarm response patterns, examples ofwhich are not limited to a particular set of independent variables oralarm response patterns.

In other examples, the alarm manager determines if acuity (or lack ofacuity) of the patient's senses may be an inhibiting factor and, if so,adapts alarms overcome these obstacles. For instance, in one example,the alarm manager administers, within the configuration interface, ahearing test. In this example, the results of the hearing test arestored in the alarm profile information and used by the alarm manager totailor the audio alarms to a specified frequency, amplitude and tonalqualities. Further, according to this example, the alarm manager issuesthe audio alarms according to the frequency, amplitude and tonalsettings when the audio alarms are triggered by an event. Theadaptations in this example enable the alarms to be perceived by theintended recipients with partial hearing loss. In another exampledesigned to address hearing loss, the alarm manager alters the conduitthrough which audio alarms are presented, instead presenting the alarmsas visual alarms through a display.

In other examples, the alarm manager receives, via the configurationinterface, an indication that the patient possesses impaired sight. Inthese examples, the alarm manager alters the conduit through whichvisual alarms are presented to a non-visual conduit. Non-visual conduitsinclude an auditory conduit (e.g., a speaker) or a tactile conduit(vibration or Braille printout). Alarms issued through a vibratingtactile conduit may simply vibrate once, vibrate repeatedly or vibrateaccording to a signature pattern, such as Morse code.

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path specifying that if no response is receivedfrom an external entity within a specified response time, the alarmmanager should determine if any bystanders are near the intendedrecipient. In these examples, the adaptation path may further specifythat where bystanders are detected, the alarm manager should adjust thecontent of the alarm to direct it to the bystanders. In one example, thealarm manager detects the presence of bystanders by determining adifference between a detected voice pattern and a sample voice patternof the intended recipient that is stored in the alarm profileinformation. According to these examples, the alarm manager issues thealarm according to the adaptation path when the alarm is triggered by anevent.

In other examples, the alarm manager determines that the patient may beasleep and, in response, increases alarm intensities and target responsetimes. In these examples, the alarm manager determines that the patientmay be asleep by analyzing any combination of a variety of factorsincluding: physiological data (such as heart rate and respiration), thecurrent time of day, and the presence (or lack) of patient motion, thebody position of the patient and the proximity of the patient to a homebase station near the patient's bed. In one example, the home basestation is configured in accord with the base unit described inapplication Ser. No. 13/286,533, entitled REMOTE MEDICAL DEVICE ALARM,filed Nov. 1, 2011, now U.S. Pat. No. 9,937,355, which is incorporatedby reference herein in its entirety. Further the alarm manager mayreceive, via the configuration interface, an adaptation path thatspecifies a multi-stage alarm in which an intense, initial “wake-up”alarm is followed by a separate alarm reporting the event of interestwith different intensity and content. Alternatively, the adaptation pathmay specify that alarms should be routed to a home base station so thatthe triggered alarms are communicated with greater intensity. Accordingto these examples, the alarm manager issues the alarm according to theadaptation path when the alarm is triggered by an event.

In other examples, the alarm manager determines that the patient may bementally or physically impaired and, in response, directs the alarm toanother intended recipient, such as a doctor, relative or othercaregiver. In these examples, the alarm manager determines that thepatient may be mentally impaired by analyzing any combination of avariety of factors including: physiological data (such as heart rate andrespiration), the presence (or lack) of patient motion, and audio input(to determine if the patient's speech is impaired).

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path that specifies that when the patient failsto take medication according to a prescribed schedule, the alarm managerissue an alarm reminding the patient to do so. In these examples, thealarm manager determines that the patient failed to take medication byanalyzing physiological data (such as heart rate and respiration) or byquestioning the patient via the user interface. In some of theseexamples, particular patterns in the physiological data may be linked toparticular medications and these links may be use to provide specificalarms to the patient. For instance, if the physiological data exhibitsa pattern indicative of congestive heart failure and that pattern islinked to lisinopril, the alarm manager may issue an alarm to remind thepatient to take a prescribed dose of lisinopril.

In other examples, the alarm manager receives, via the configurationinterface, an adaptation path that specifies adjustments of theintensity, issuance rate or duration of an alarm based on the severityof the event of interest. For instance, in some examples in which thewearable medical device controller is incorporated into a wearabledefibrillator, the adaptation path may define particular alarmcharacteristics to indicate the number and type of electrodes that arenot properly positioned on the patient's body. In one example, theadaptation path may specify different tones to indicate incorrectpositioning for ECG electrodes and therapy pads. Similarly, in thisexample, the adaptation path may specify increasing alarm intensities toindicate increasing numbers of electrodes being out of position.According to these examples, the alarm manager issues the alarmaccording to the adaptation path when the alarm is triggered by anevent.

In other examples, the alarm manager is trained by the patient, via theconfiguration interface, to detect one or more locations, such as a car,office or home, frequently visited by the patient. In one of theseexamples, the alarm manager receives a location identifier from a uservia the configuration interface, records and stores informationrepresentative of the ambient noise within the location and creates andstores an association between the location and the stored ambient noiseinformation. In another of these examples, the alarm manager receives alocation identifier from a user via the configuration interface, recordsand stores information representative of the current GPS position of thewearable medical device controller and creates and stores an associationbetween the location and the current GPS position. According to theseexamples, the alarm manager automatically detects the location of thewearable medical device controller, sets the alarm mode parameter to avalue associated with the location and adjusts the triggered alarmsaccordingly (both according to the alarm mode parameter in general andas defined by the adaptation paths associated with the alarms).

In a particular example, where the alarm mode parameter indicates thepatient is occupying a vehicle, the alarm manager issues, via thenetwork interface 106, alarms to the patient through an in-vehiclecommunications and entertainment system, such as OnStar, SYNC, MyFordTouch, BMW Assist and Lexus Link, that allows users to make hands-freetelephone calls and control music and other functions using voicecommands. In this example, the alarm manager provides an interface tothe patient via the in-vehicle communications and entertainment system.In addition, according to this example, the alarm manager may employ thefacilities of the in-vehicle communications system to issuenotifications to intended recipients other than the patient, for examplesending a request for help to monitoring or emergency personnel.

According to another example, where the alarm mode parameter indicatesthe patient is at home, the alarm manager issues, via the networkinterface 106, alarms to the patient through a home security system thatallows users to make hands-free telephone calls and control functionsusing voice command or through a television or computer located withinthe home of the patient. In this example, the alarm manager provides aninterface to the patient via the home security system, television orcomputer. In addition, according to this example, the alarm manager mayemploy the facilities of the home security system to issue notificationsto intended recipients other than the patient, for example sending arequest for help to monitoring or emergency personnel.

According to another example, where the alarm mode parameter indicatesthe patient using a personal electronic device, the alarm managerissues, via the network interface 106, alarms to the patient through thepersonal electronic device. In this example, the alarm manager providesan interface to the patient via the personal electronic device. Inaddition, according to this example, the alarm manager may employ thefacilities of the personal electronic device to issue notifications tointended recipients other than the patient, for example sending arequest for help to monitoring or emergency personnel. Moreover, thealarm manager may preempt the normal functioning of the personalelectronic device when issuing alarms. For instance, where the personalelectronic device is being used to make a phone call, the alarm managermay send alarms and messages into the phone so they can be heard from anexternal entity. In another example, the personal electronic device mayinclude a light, buzzer or some other sensory output that is activatedby the alarm manager when the alarm manager issues an alarm.

In yet another example, a sensory output, such as a light, is positionedwithin the field of vision of a patient by being integrated into a pairof glasses that are worn by the patient. According to this example, thealarm manager activates the light when issuing an alarm, therebynotifying the patient of the alarm.

In other examples, the alarm manager provides a user interface, via theuser interface 108, that receives and responds to voice commands.According to this example, the alarm manager validates the identity ofthe speaker by verifying that the voice pattern matches a voice patternstored in data storage, such as the data storage 104. Further, accordingto this example, the configuration interface receives and responds tovoice commands and allows external entities, such as the patient ormonitoring personnel to configure alarm information using voicecommands.

Having thus described several aspects of at least one embodiment of thisinvention, it is to be appreciated various alterations, modifications,and improvements will readily occur to those skilled in the art. Suchalterations, modifications, and improvements are intended to be part ofthis disclosure, and are intended to be within the scope of theinvention. Accordingly, the foregoing description and drawings are byway of example only.

What is claimed is:
 1. A wearable defibrillator comprising: one or more environmental sensors comprising an accelerometer; one or more electrocardiogram (ECG) sensors configured to acquire ECG data; and an alarm manager and at least one processor operatively coupled to the one or more ECG sensors and the accelerometer, and configured to detect a cardiac abnormality in a patient based on the ECG data, identify a notification to be issued that is associated with the detected cardiac abnormality in the patient, the notification having one or more characteristics, detect an environmental condition of the wearable defibrillator based on one or more environmental parameters, wherein the accelerometer is configured to detect a presence or lack of patient motion, and/or detect a body position of the patient as the detected environmental condition, determine, based on the detected environmental condition, whether one or more factors exist that inhibit the patient's ability to recognize the notification associated with the detected cardiac abnormality in the patient, on determining the existence of the one or more factors that inhibit the patient's ability to recognize the notification associated with the detected cardiac abnormality in the patient, adapt the one or more characteristics of the notification and provide an adapted notification associated with the detected cardiac abnormality in the patient, and issue the adapted notification associated with the detected cardiac abnormality in the patient.
 2. The wearable defibrillator of claim 1, wherein the notification associated with the detected cardiac abnormality in the patient comprises an auditory alarm, and the one or more characteristics of the notification comprise an intensity of the auditory alarm.
 3. The wearable defibrillator of claim 2, wherein adapting the one or more characteristics of the notification comprises adjusting an amplitude of the auditory alarm.
 4. The wearable defibrillator of claim 2, wherein adapting the one or more characteristics of the notification comprises adjusting a frequency of the auditory alarm.
 5. The wearable defibrillator of claim 1, wherein the one or more characteristics of the notification comprise an issuance rate of the notification.
 6. The wearable defibrillator of claim 5, wherein adapting the one or more characteristics of the notification comprises increasing the issuance rate of the notification.
 7. The wearable defibrillator of claim 1, wherein the one or more characteristics of the notification comprise content of the notification.
 8. The wearable defibrillator of claim 7, wherein adapting the one or more characteristics of the notification comprises adjusting the content of the notification to direct the notification to one or more bystanders.
 9. The wearable defibrillator of claim 7, wherein the notification associated with the detected cardiac abnormality in the patient comprises an auditory alarm, and wherein adapting the one or more characteristics of the notification comprises changing the auditory alarm from a gentle sound to an ear-piercing sound.
 10. The wearable defibrillator of claim 7, wherein the notification associated with the detected cardiac abnormality in the patient comprises an auditory alarm, and wherein adapting the one or more characteristics of the notification comprises changing the auditory alarm from a tone to a voice command.
 11. The wearable defibrillator of claim 10, wherein the one or more characteristics of the notification further comprise an intensity of the auditory alarm.
 12. The wearable defibrillator of claim 11, wherein adapting the one or more characteristics of the notification further comprises adjusting an amplitude of the auditory alarm.
 13. The wearable defibrillator of claim 10, wherein the one or more characteristics of the notification further comprise an issuance rate of the notification, and wherein adapting the one or more characteristics of the notification further comprises increasing the issuance rate of the notification.
 14. The wearable defibrillator of claim 10, wherein the at least one processor is further configured to determine whether a response from the patient has been received after the issuance of the adapted notification associated with the detected cardiac abnormality in the patient.
 15. The wearable defibrillator of claim 10, further comprising at least one defibrillator electrode operably coupled to the at least one processor and configured to treat the patient.
 16. The wearable defibrillator of claim 1, wherein the one or more characteristics of the notification comprise a conduit of the notification.
 17. The wearable defibrillator of claim 1, wherein adapting the one or more characteristics of the notification comprises changing the notification from a tactile notification to an auditory notification.
 18. The wearable defibrillator of claim 1, wherein determining, based on the detected environmental condition, whether the one or more factors exist that inhibit the patient's ability to recognize the notification associated with the detected cardiac abnormality in the patient comprises determining whether an ambient noise level is above a predetermined threshold.
 19. The wearable defibrillator of claim 1, wherein determining, based on the detected environmental condition, whether the one or more factors exist that inhibit the patient's ability to recognize the notification associated with the detected cardiac abnormality in the patient comprises determining whether the patient is asleep.
 20. The wearable defibrillator of claim 19, wherein the determination of whether the patient is asleep is based on the presence of lack of patient motion, and/or the body position of the patient.
 21. The wearable defibrillator of claim 20, wherein the determination of whether the patient is asleep is further based on at least one of a heart rate of the patient or respiration of the patient.
 22. The wearable defibrillator of claim 19, wherein the at least one processor is further configured to determine whether a response from the patient has been received.
 23. The wearable defibrillator of claim 22, wherein the at least one processor is further configured to, in response to determining that the patient is asleep, increase a target response time for the response from the patient.
 24. The wearable defibrillator of claim 23, wherein the notification associated with the detected cardiac abnormality in the patient comprises an auditory alarm, and the one or more characteristics of the notification comprise an intensity of the auditory alarm.
 25. The wearable defibrillator of claim 24, wherein adapting the one or more characteristics of the notification comprises adjusting an amplitude of the auditory alarm.
 26. The wearable defibrillator of claim 24, wherein adapting the one or more characteristics of the notification comprises adjusting a frequency of the auditory alarm.
 27. The wearable defibrillator of claim 23, wherein the one or more characteristics of the notification comprise an issuance rate of the notification, and wherein adapting the one or more characteristics of the notification comprises increasing the issuance rate of the notification.
 28. The wearable defibrillator of claim 23, wherein the at least one processor is further configured to determine whether a response from the patient has been received after the issuance of the adapted notification associated with the detected cardiac abnormality in the patient.
 29. The wearable defibrillator of claim 23, further comprising at least one defibrillator electrode operably coupled to the at least one processor and configured to treat the patient.
 30. The wearable defibrillator of claim 1, wherein the at least one processor is further configured to determine whether a response from the patient has been received after the issuance of the adapted notification associated with the detected cardiac abnormality in the patient.
 31. The wearable defibrillator of claim 1, further comprising at least one defibrillator electrode operably coupled to the at least one processor and configured to treat the patient. 